NCT05892120|Unknown
A Smartphone App on Medication Adherence
App
The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia
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App
The Effectiveness of a Smartphone App on Medication Adherence and Psychotic Symptoms and Cognitive Functions in Patients With Schizophrenia
Sponsor study identifier
observational
100
1 country
1
Study Start
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 25, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is an experimental study which aims to explore the effectiveness of a smartphone app for medication adherence (MedAdhere app) among schizophrenic patients for eight weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2023
Actual (reported)June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 7, 2023
Actual (reported)July 25, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
psychiatric symptoms
The positive and negative syndrome scale was used to measure participants' psychiatric symptoms. Of the 30 items on the scale, seven are positive symptoms, seven are negative symptoms, and 16 are general psychopathology symptoms. Symptom severity for each item is rated according to the anchoring points in the 7-point scale (1 = absent; 7 = extreme) that best describe the symptom (Kay et al., 1987). The PANSS score is the sum of ratings across items, ranging from 7 to 49 for the Positive, Negative Scales, and 16 to 112 and 16 to 112 for the General Psychopathology Scale.
Change from Baseline psychiatric symptoms at 8 weeks
cognitive functions
The Mini-Mental State Examination was used to measure participants' cognitive functions. The MMSE consists of 15 questions for assessing the following seven cognitive domains: orientation in time and place, memory registration and recall, attention and calculation, and language. The total MMSE score ranged from 0 to 30, and higher scores indicate better cognitive functions.
Change from Baseline cognitive functions at 8 weeks
Medication adherence rate
Utilizing cloud-based platforms to compute the medication adherence rate.
Change from Baseline Medication adherence' rate at 8 weeks
The control group only received usual care, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after 8 weeks.
The experimental group use the MedAdhere app for eight weeks, the PANSS and MMSE were used to assess psychiatric symptoms and cognitive functions before (week 0) and after (week 8) intervention.
The experimental group downloaded and used the MedAdhere app on their personal smartphones during this 8-week study
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Schizophrenia is a brain disorder that is possibly related to the reduction of neural connections in the prefrontal cortex or imbalances in dopaminergic neurons in brain. It can be induced by genetic, social, physiological, psychological, and other factors, resulting in cognitive, emotional, behavioural, and perception dysfunction. At present, new generations of anti-psychotic drugs have become available, allow patients to stabilise their condition with less side effect by receiving regular drug treatment. However, medication non-adherence can cause disorder progression, compromise the patient's quality of life, and increase medical expenses
Kaohsiung Medical University
Kaohsiung City, 80708, Taiwan
Chen HH, Hsu HT, Lin PC, Chen CY, Hsieh HF, Ko CH. Efficacy of a Smartphone App in Enhancing Medication Adherence and Accuracy in Individuals With Schizophrenia During the COVID-19 Pandemic: Randomized Controlled Trial. JMIR Ment Health. 2023 Dec 14;10:e50806. doi: 10.2196/50806.
First Submitted
May 16, 2023
First Posted
June 7, 2023
Study Start
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 25, 2023
Phenotyping Adherence Through Technology-Enabled Reports and Navigation
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 7, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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